Health product recall

LEEP PRECISION Integrated System and Generator 2019-06-02)

Starting date:
June 2, 2019
Posting date:
June 14, 2019
Type of communication:
Medical Device Recall
Subcategory:
Medical Device
Hazard classification:
Type II
Source of recall:
Health Canada
Issue:
Medical Devices
Audience:
General Public, Healthcare Professionals, Hospitals
Identification number:
RA-70215

Last updated: 2019-06-14

Affected Products

A. LEEP PRECISION Integrated System
B. LEEP PRECISION Generator

Reason

CooperSurgical is conducting a medical device safety alert for five (5) LEEP PRECISION Integrated System and generator units distributed to Canada (358 total units distributed) because of the possibility that the generator may lose power intermittently when using the foot pedal.  The LEEP PRECISION Integrated System unit will then cease to cut, coagulate, or blend tissue during a procedure.

Affected products

A. LEEP PRECISION Integrated System

Lot or serial number

2015110019

2017050005

Model or catalog number

LP-10-120

Companies
Manufacturer

Coopersurgical Inc.

95 Corporate Drive

Trumbull

06611

Connecticut

UNITED STATES

B. LEEP PRECISION Generator

Lot or serial number

2016080033

0036

2016100033

Model or catalog number

LP-20-120

Companies
Manufacturer

Coopersurgical Inc.

95 Corporate Drive

Trumbull

06611

Connecticut

UNITED STATES